Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair

NCT07612839 | Not Yet Recruiting

• 1 other identifier: 25-42
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized placebo-controlled trial aims to evaluate the effect of perioperative intravenous lidocaine on postoperative fatigue in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Participants will be randomly assigned to receive either intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo. The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). Secondary outcomes include postoperative pain, cumulative tramadol consumption, postoperative nausea and vomiting, and the requirement for additional analgesia.

Conditions

Postoperative Fatigue Syndrome; Inguinal Hernia Unilateral

Keywords

Intravenous Lidocaine; Postoperative Fatigue; Laparoscopic TAPP Repair; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• MFI-20 Physical Fatigue Subscale Score

  Postoperative physical fatigue will be assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20). The Physical Fatigue subscale consists of four items and ranges from 4 to 20 points, with higher scores indicating greater physical fatigue. A preoperative assessment will be obtained as the baseline value. Postoperative assessments will be performed on postoperative days 1, 3, 5, and 7.

  Preoperative baseline and postoperative days 1, 3, 5, and 7

Secondary Outcomes (4)

• Postoperative Pain Intensity (11-point Numeric Rating Scale)

  2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7

• Postoperative Nausea and Vomiting Within 24 Hours

  First 24 hours after surgery

• Cumulative Tramadol Consumption During the First 24 Postoperative Hours

  First 24 hours after surgery

• Requirement for Additional Analgesia During the First 24 Postoperative Hours

  First 24 hours after surgery

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Participants in this group will receive intravenous lidocaine based on ideal body weight. A loading dose of 1.5 mg/kg will be administered intravenously over 10 minutes before surgery, followed by a continuous infusion of 1.5 mg/kg/hour until the end of surgery. The infusion will be discontinued if signs suggestive of local anesthetic systemic toxicity or clinically significant unexplained hemodynamic or cardiac conduction abnormalities occur.

Drug: Lidocaine

Control Group

PLACEBO COMPARATOR

Participants in this group will receive an equal-volume 0.9% sodium chloride placebo administered according to the same timing and infusion protocol as the lidocaine group. Standard perioperative care will otherwise be identical between groups.

Drug: 0.9 % sodium chloride

Interventions

0.9 % sodium chloride DRUG

0.9% sodium chloride will be administered intravenously as placebo in an equal volume and according to the same timing and infusion protocol as the lidocaine intervention.

Control Group

Lidocaine DRUG

Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.

Lidocaine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years
• Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair
• American Society of Anesthesiologists (ASA) physical status I or II
• Able to understand and complete the Multidimensional Fatigue Inventory-20 (MFI-20)
• Written informed consent provided

You may not qualify if:

• Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics
• Clinically significant hepatic or renal dysfunction
• Clinically significant cardiac rhythm or conduction disorder
• Chronic opioid use
• Regular use of antiarrhythmic medication
• Pregnancy or breastfeeding
• Planned use of an additional local anesthetic technique during the study intervention
• Inability to complete the study assessments

Sponsors & Collaborators

• Hakan Emirkadı: lead

Study Sites (1)

University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Hakan Emirkadı, MD

CONTACT

+905322609367; hemirkadi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, anesthesia care providers, and postoperative outcome assessors will be blinded to treatment allocation. Study solutions will be prepared in identical volumes and appearance by an authorized individual not involved in postoperative outcome assessment or clinical care. Emergency unblinding will be permitted when required for participant safety.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Model Details: Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)